Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of a Single Ascending Dose (SAD) of CAN106 Administered Intravenously (IV) in Healthy Subjects

Phase 1

Completed

• Conditions: PNH
• Interventions: Drug: CAN106; Drug: Placebo

• Registration Number: NCT05095168
• Lead Sponsor: CARE Pharma Shanghai Ltd.

Brief Summary

This is a single site, single dose escalation study in healthy subject with CAN106. The study is to assess the safety and tolerability of single escalating doses of CAN106; to characterize the PK and PD profile of CAN106; and to evaluate the immunogenicity of CAN106 injection.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-02-22
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2021-10-14
• Study First Posted: 2021-10-27
• Primary Completion: 2021-11-30
• Study Completion: 2021-11-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-19
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Subjects must be able to understand and provide informed consent.
• Males or females, between 21 and 45 years of age, inclusive;
• Body mass index must be within the range of 18.5 to 32.0 kg/m2;
• 12-lead electrocardiogram (ECG) within normal limits with no clinically significant abnormalities in the opinion of the Investigator；
• Systolic blood pressure ≤140 mmHg and a diastolic blood pressure of ≤ 90 mmHg after 5 minutes with supine rest；
• non-pregnancy
• meningococcal vaccinations for at least 2 weeks before dosing

Exclusion Criteria

• Disease or conditions interfere with participating the trial
• Active serious mental illness or psychiatric disorder
• clinically relevant abnormal test results in hepatic function
• unacceptable CBC lab test
• asymptomatic complement deficiency
• Any other clinical safety laboratory test
• HIV, HBV, HCV positive
• Alcohol and drug abuse
• etc.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Single Ascending Dose (SAD)	CAN106	In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). Additional subjects may be added in any cohort if necessary.
placebo	Placebo	In the SAD arm subjects will be sequentially included in one of up to six cohorts (dose levels). In higher dose levels, subjects will be randomized to receive the treatment or placebo.

Primary Outcome Measures

Name	Time	Method
Incidence of subjects with dose-limiting toxicity (DLTs)	6-months after dosing	TEAEs will be categorized as per the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria.; a DLT is defined as one subject with a Grade 3 AE or higher, that are assessed as drug-related by the site investigator.
Incidence of adverse events (AEs)	6-months after dosing	An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Incidence of severe adverse events (SAEs)	6-months after dosing	Any untoward medical occurrence that at any dose: * Results in death,; * Is life-threatening,; * Requires inpatient hospitalization or prolongation of existing hospitalization,; * Results in persistent or significant disability/incapacity, or; * Is a congenital anomaly/birth defect. (ICH E6 (R2))

Secondary Outcome Measures

Name	Time	Method
PK parameters - tmax	6-months after dosing	time to reach maximum of concentration (days)
Immunogenicity	6-months after dosing	Anti-drug Antibody (ADA) titers
PK parameters-Cmax	6-months after dosing	peak plasma concentration
PK parameters - AUC0-t	6-months after dosing	Area under the plasma concentration versus time curve to the last visit (AUCt)
PK parameters - t1/2	6-months after dosing	terminal elimination half-life
PD endpoints-free C5	6-months after dosing	maximal change from baseline in free C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);
PD endpoints-CH50	6-months after dosing	maximal change from baseline total complement activity (CH50) at each of scheduled post baseline assessment time-points (%);
PD endpoints-total C5	6-months after dosing	meausure the absolute change from baseline in total C5 concentrations at each of scheduled post baseline assessment time-points (µg/ml);

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore